Stoma or intestinal anastomosis for necrotising enterocolitis of the neonate
Not Applicable
Completed
- Conditions
- ecrotising enterocolitisPregnancy and ChildbirthNecrotising enterocolitis of fetus and newborn
- Registration Number
- ISRCTN01700960
- Lead Sponsor
- Great Ormond Street Hospital for Children NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
1. Suspected NEC
2. Need for laparotomy based on:
2.1. Radiological signs of intestinal perforation or
2.2. Failure of improvement with medical treatment
3. Aged 0 - 6 months, either sex
Exclusion Criteria
1. No evidence of NEC (e.g. intestinal volvulus)
2. Focal intestinal perforation (since many surgeons would not perform a stoma)
3. Extensive NEC precluding intestinal anastomosis (intestinal resection will result in short bowel)
4. NEC affecting the colon that cannot be completely assessed because of risk of bleeding
5. Patient's instability during the operation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of parenteral nutrition (days), as this reflects the recovery of intestinal function after NEC and will be affected by complications and/or need for further procedures.
- Secondary Outcome Measures
Name Time Method